Sr. Clinical Trial Manager – IGM Biosciences – Mountain View, CA

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.

We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, and we have initiated a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkin’s lymphoma (NHL) patients in 2019. Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies, for which we have recently initiated a Phase 1 clinical trial. Also in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.

We are seeking an experienced Sr. Clinical Trial Manager to successfully manage and execute one or more clinical trials/programs with minimal supervision, starting from First in Human Phase I studies, primarily conducted in the U.S and primarily in Oncology indications. Must be able to manage all clinical operational aspects of a clinical trial/program from start-up, site selection, enrollment, maintenance, and close-out. Must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc.

Qualifications:

• Bachelor’s degree or equivalent is required.
• Ideal candidate will have at least 10 years of relevant experience in either sponsor or CRO (at least 4 years clinical trial management experience).
• Strong track record for successful study initiation and execution.
• Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.
• Relevant therapeutic area and Phase I experience highly preferred.
• Experience managing CROs and third-party vendors.
• Experience in Finance Management (Budget Forecasting, Change Order management, etc.).
• Experience working with EDC, CTMS, and eTMF system.
• Strong interpersonal communication skills.
• Excellent cross-functional clinical project management skills.
• Must have exceptional leadership skills, including motivation and delegation.

Responsibilities:

• Provide leadership and oversight in all aspects of clinical operations from planning and executing 1 or more complex oncology clinical trials/programs (site selection, start-up, enrollment, maintenance and close-out).
• Provide strategic operational input to Clinical Development Plan (CDP) and project plans.
• Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities.
• Develop and maintain enrollment and budget forecast.
• Manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget.
• Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management.
• Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings.
• Responsible for oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up).
• Develop and review SOPs and processes, guidelines for compliance with global regulatory requirements.
• Develop study plans, including vendor oversight, risk, safety, communication.
• Provide supervision, coach and mentoring, and contribute to hiring new staff.
• Proactively identify risks, develop and implement mitigation strategies.
• Self-motivated and able to thrive in a fast-paced, start-up environment.
• Able to travel (<20%)

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

We offer a fast-paced, collaborative, team-based and family-like work environment. It is one of our biggest goals to maintain our company culture.

One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering a robust and comprehensive benefits with a variety of options:

• Medical, dental and vision insurance. The full premium amount for our employees and their dependents is currently covered by IGM
• STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
• 401(k) Plan
• 120 hours of Paid Time Off, 5 sick days per year, 10 holidays
• Cell phone & internet subsidy
• Employee Referral Bonus Program
• Annual training budget for professional development
• Commuter Benefit
• Annual bonus program
• New hire stock options